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Trial record 9 of 13 for:    "Lung Disease" | "Beractant"

Aerosolized Surfactant in Neonatal RDS (AS-02)

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ClinicalTrials.gov Identifier: NCT02294630
Recruitment Status : Active, not recruiting
First Posted : November 19, 2014
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sood, Beena G., MD, MS

Brief Summary:
Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause of mortality and morbidity in preterm infants. Intratracheal instillation, the only approved means of surfactant delivery, requires endotracheal intubation and mechanical ventilation with their attendant risks. Interventions that decrease need for intubation and mechanical ventilation like noninvasive ventilation (NIV) including nasal continuous positive airway pressure, high flow nasal cannula or nasal intermittent mandatory ventilation are increasingly being used for initial respiratory support in preterm neonates with RDS to improve outcomes. Aerosolized surfactant delivered during NIV is an innovative and promising concept for the treatment of RDS - retaining the advantages of early surfactant with alveolar recruitment while obviating the risks of intubation and mechanical ventilation. The investigators overall hypothesis is that treatment of RDS with aerosolized surfactant in preterm infants undergoing NIV is safe and feasible and will result in short-term improvement in oxygenation and ventilation. The objective of this proposal is to perform a single-center unblinded Phase II randomized clinical trial of aerosolized surfactant for the treatment of RDS in preterm neonates undergoing NIV. Funding Source - FDA-OOPD.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn Drug: Surfactant Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aerosolized Survanta in Neonatal Respiratory Distress Syndrome: Phase I/II Study
Study Start Date : December 2014
Actual Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Active Comparator: Surfactant Dose - 100
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg.
Drug: Surfactant
Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Other Name: Survanta

Active Comparator: Surfactant Dose - 200
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg.
Drug: Surfactant
Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Other Name: Survanta




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Feasibility [ Time Frame: During and within 6 hours after end of study drug administration, expected maximum of approximately 14 hours ]
  2. The optimal dose of aerosolized surfactant [ Time Frame: During study drug administration, expected maximum of approximately 8 hours ]
  3. Short term efficacy as assessed by need for intubation [ Time Frame: Within 72 hours of study intervention ]

Secondary Outcome Measures :
  1. Blood gas parameters [ Time Frame: 60±30 minutes after end of study intervention ]
  2. Pulse oximetry [ Time Frame: 60±30 minutes after end of study intervention ]
  3. Vital signs [ Time Frame: 60±30 minutes after end of study intervention ]
  4. Number of doses of surfactant - aerosolized & intratracheal [ Time Frame: Within 72 hours of study intervention ]
  5. Pneumothorax, pneumomediastinum or other air leak [ Time Frame: Within 72 hours of study intervention ]
  6. Changes in cerebral oxygenation as evaluated [ Time Frame: During and within 6 hours after end of study intervention, expected maximum of approximately 14 hours ]
  7. Changes in surfactant activity in gastric aspirates [ Time Frame: During study intervention, expected maximum of approximately 8 hours ]
  8. Cumulative duration of non-invasive and invasive ventilation [ Time Frame: on days 3, 7, 14, 28; 36 weeks corrected GA and at discharge ]
  9. Duration of supplemental oxygen, intensive care, hospital stay [ Time Frame: During initial hospital stay, expected <= 120 days ]
  10. Age at start of feeds, feeding progression, age at full enteral feeds [ Time Frame: During initial hospital stay, expected 1st 2 weeks of life ]
  11. Need for blood transfusions [ Time Frame: During initial hospital stay, expected <= 120 days ]
  12. Growth parameters [ Time Frame: At 7 days, 28 days, 36 weeks corrected GA and discharge ]
  13. Morbidities associated with prematurity [ Time Frame: During initial hospital stay, expected <= 120 days ]
  14. Survival to hospital discharge [ Time Frame: During initial hospital stay, expected <= 120 days ]
  15. Survival to discharge without severe morbidity [ Time Frame: During initial hospital stay, expected <= 120 days ]


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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants admitted to the NICU at Hutzel Women's Hospital (HWH)/Children's Hospital of Michigan (CHM)
  2. Gestational age of 240/7-366/7 weeks
  3. Postnatal age ≤ 24 hours
  4. Clinical diagnosis of RDS based on (i) presence of at least two of the four classic symptoms (need of supplemental oxygen, tachypnea, intercostal retractions or grunting), and (ii) exclusion of other causes of respiratory failure and (iii) Clinician intent to administer surfactant if infant requires intubation
  5. Respiratory support with NIV (CPAP or NIPPV or HFNC) with FiO2 ≥25% or PEEP ≥ 4 cmH20 or HFNC rate ≥ 2 LPM for ≤8 hours
  6. Written informed consent from parent/guardian

Exclusion Criteria:

  1. Previous receipt of surfactant
  2. Infants with respiratory distress who are unstable and require immediate intubation
  3. Active air leak syndrome (e.g. pneumothorax, pneumomediastinum)
  4. Lethal congenital malformations; death anticipated within first 3 days of life; decision to withhold support
  5. Serious abdominal, cardiac, airway or respiratory malformations including tracheal esophageal fistula, intestinal atresia, omphalocele, gastroschisis, pulmonary hypoplasia, or diaphragmatic hernia
  6. Neuromuscular disorder resulting in respiratory compromise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294630


Locations
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United States, Michigan
Hutzel Women's Hospital
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Sood, Beena G., MD, MS
Investigators
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Principal Investigator: Beena G. Sood, MD, MS Wayne State University

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Responsible Party: Sood, Beena G., MD, MS
ClinicalTrials.gov Identifier: NCT02294630     History of Changes
Other Study ID Numbers: 1206011023
1R01FD004793-01A1 ( U.S. FDA Grant/Contract )
FD004793 ( Other Identifier: FDA - OOPD )
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Lung Diseases
Beractant
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Disease
Pathologic Processes
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents